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Clinical Research Coordinator 1

3 months ago

Miami, United States The University of Miami Full time
Current Employees:

If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.

The Department of Dermatology has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work in Miami, FL. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.
  • Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
  • Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
  • Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
  • Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
  • Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
  • Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
  • Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
  • Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
  • Knows the contents and maintenance of study-specific clinical research regulatory binders.
  • Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
  • Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

MINIMUM QUALIFICATIONS
  • Bachelor's degree in relevant field
  • Minimum 1 year of relevant experience
  • Skill in completing assignments accurately and with attention to detail.
  • Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
  • Ability to process and handle confidential information with discretion.
  • Ability to work evenings, nights, and weekends as necessary.
  • Commitment to the University's core values.
  • Ability to work independently and/or in a collaborative environment.

DEPARTMENT SPECIFIC FUNCTIONS
  • Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
  • Create and design appropriate templates as Source Documents for Sponsor Initiated and Investigator initiated Studies.
  • Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
  • Manage coordination of facilities monitoring, auditing visits, site evaluations and Initiation visits.
  • Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants.
  • Establishes/maintains contact with patient/participants, health care providers, community agencies and study sponsors.
  • Minimum 3 years of experience (preferred)
  • Clinical coordinator certification (preferred)

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:
Full time

Employee Type:
Staff

Pay Grade:
A8